(26 days)
The Atrium Graduated Wall Flixene Ax-Bifem Graft is intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Not Found
I am sorry, but the provided text does not contain the information requested to describe the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) clearance letter from the FDA for a vascular graft, which primarily confirms substantial equivalence to a predicate device and outlines regulatory responsibilities. It does not include details about device performance metrics, study design, sample sizes, expert qualifications, or ground truth establishment.
§ 870.3450 Vascular graft prosthesis.
(a)
Identification. A vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access. It is commonly constructed of materials such as polyethylene terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or collagen, or a synthetic coating, such as silicone. The graft structure itself is not made of materials of animal origin, including human umbilical cords.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular Prostheses 510(k) Submissions.”